Semuloparin for the extended prevention of a mortality and/or morbidity event in a patient having undergone hip fracture surgery

Abstract

The invention relates to the use of semuloparin or a pharmaceutically acceptable salt thereof for the extended prevention of a mortality and/or morbidity event, more specifically venous thromboembolism and death, in a patient having undergone hip fracture surgery.

What is claimed is: 
     
         1 . A method for the extended prevention of a mortality or morbidity event in a patient having undergone hip fracture surgery, wherein said event is selected from venous thromboembolism and death, and wherein the efficacy of said use is clinically proven by a phase III clinical trial, the method comprising administering an effective dose of an ultra-low molecular weight heparin with an average molecular weight of 2000 to 3000 Daltons, an anti-Factor Xa activity of 145 to 180 U/mg and an anti-Factor IIa activity of less than 5 U/mg. 
     
     
         2 . The method according to  claim 1 , wherein said ultra-low molecular weight heparin is semuloparin or a pharmaceutically acceptable salt thereof. 
     
     
         3 . The method according to  claim 1 , wherein said method results in at least a 79% relative risk reduction in the occurrence of venous thromboembolism and death. 
     
     
         4 . The method according to  claim 1 , for use in the extended prevention of venous thromboembolism, including deep vein thrombosis, non-fatal pulmonary embolism and death. 
     
     
         5 . The method according to  claim 1 , for use in the extended prevention of deep vein thrombosis. 
     
     
         6 . The method according to  claim 5 , wherein said method results in a relative risk reduction of at least 77% in the occurrence of deep vein thrombosis. 
     
     
         7 . The method according to  claim 1 , for use in the extended prevention of proximal deep vein thrombosis. 
     
     
         8 . The method according to  claim 7 , wherein said use results in a relative risk reduction of at least 83% in the occurrence of proximal deep vein thrombosis. 
     
     
         9 . The method according to  claim 1 , for use in the extended prevention of distal deep vein thrombosis. 
     
     
         10 . The method according to  claim 9 , wherein said use results in a relative risk reduction of at least 71% in the occurrence of distal deep vein thrombosis. 
     
     
         11 . The method according to  claim 2 , wherein semuloparin is administered at a 20 mg daily dose to patients with normal renal function or to patients with mild or moderate renal impairment. 
     
     
         12 . The method according to  claim 2 , wherein semuloparin is administered at a 10 mg daily dose in patients with severe renal impairment. 
     
     
         13 . The method according to  claim 2 , wherein the dose is administered once daily. 
     
     
         14 . The method according to  claim 2 , wherein the dose is administered for 26 to 33 days, starting from the day of surgery. 
     
     
         15 . An article of manufacture comprising:
 a packaging material,   a compound chosen from an ultra-low molecular weight heparin (ULMWH) with an average molecular weight of 2000 to 3000 Daltons, an anti-FXa activity of 145 to 180 U/mg and an anti-FIIa activity of less than 5 U/mg, and   a label or package insert contained within said packaging material indicating that said compound is effective for the extended prevention of venous thromboembolism and death in patients having undergone hip fracture surgery.   
     
     
         16 . The article according to  claim 15  wherein the ULMWH is semuloparin or a pharmaceutically acceptable salt thereof.